Balloon catheter

ABSTRACT

An improved balloon catheter has a catheter body with an expandable member, such as a balloon, mounted to the exterior surface thereof. Preferably, means for preventing sticking of the expandable balloon to the exterior surface of the catheter body are provided. In one aspect, the catheter has an expandable member, preferably a balloon, positioned substantially equidistant from the proximal and distal ends of the catheter body. The retention catheter is positioned externally of the heart and partially surrounds the heart so that the balloon is positioned immediately adjacent the coronary sinus and when inflated, the balloon bears against the coronary sinus and at least one of the inferior vena cava and diaphragm thereby preventing inadvertent movement or removal of the RCSP catheter from the coronary sinus.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an improved balloon catheter and, morespecifically, to a catheter incorporating means adapted to prevent thesticking of the expandable member or balloon to the catheter. In anotheraspect, the invention relates to a catheter for use in coronary bypasssurgery positioned externally of the heart and adapted to assist in theretention of a retrograde cardioplegia solution perfusion ("RCSP")catheter in the coronary sinus.

2. Description of the Related Art

Catheters having an expandable member provided thereon have a widevariety of applications in numerous, different, medical procedures. Oneknown structure for such a catheter comprises an expandable member orballoon provided on the outside surface thereof wherein the balloon isexpandable between a retracted state and an expanded state. In theretracted state, the balloon can be a "tight-fitting" balloon which isinflated through the application of a pressurized fluid to the interiorof the balloon. One problem inherent with such tight-fitting balloons isthe uneven inflation of the balloon upon the application of apressurized fluid to the balloon interior. In drastic cases, portions ofthe balloon remain tacked to the exterior surface of the catheter bodywhen the balloon is in the fully-inflated position. This can result inthe balloon, in the expanded shape, assuming an undesirable,unpredictable configuration. In addition, tacking of the balloon canresult in excessive elongation of portions of the balloon body.

As noted above, balloon catheters have a wide variety of applications,only one of which is used during coronary bypass surgical procedures.Perfusion of a heart during coronary bypass surgery with cardioplegiasolution can be performed retrograde, antigrade, or a combination ofretro and antigrade. During the retrograde profusion process, a catheteris first typically inserted into the right atrium through an appropriateincision and then inserted through the ostia into the coronary sinus.Next, an expandable member, such as a balloon which is provided on thecatheter, is inflated inside the coronary sinus to occlude this vessel.Cardioplegia solution is forced through the catheter into the coronarysinus to perfuse the heart tissue. Examples of known retrogradecatheters are seen in U.S. Pat. No. 5,395,330 issued Mar. 7, 1995 toMarcadis et al. and U.S. Pat. No. 5,505,698 issued Apr. 9, 1996 to Boothet al.

One problem with the known RCSP process is possible movement ordislodging of the RCSP catheter from the coronary sinus as a result ofthe fluid pressure generated inside the coronary sinus. Excessivemovement of the inflated RCSP catheter could result in leaking ofcardioplegia solution from the coronary sinus back into the rightatrium.

Another problem experienced by some patients during the retrogradeperfusion process is insufficient perfusion of the heart tissue as aresult of leaking of solution from the middle cardiac vein and the smallcardiac vein back into the right atrium. When perfusion solution isallowed to drain from the veins back into the right atrium, thecardioplegia solution being perfused through the tissue will seek thepath of least resistance and drain into these veins rather thancompletely perfusing the heart tissue.

SUMMARY OF THE INVENTION

The improved balloon catheter and method for using the same overcomesthe problems of the prior art by providing means for preventing theinadvertent sticking or tacking of the inflatable member to the exteriorsurface of the catheter as the inflatable member is expanded. Thecatheter and method for using the same also overcomes the problems ofthe prior art by providing means for effectively sealing the middle andsmall cardiac veins during the retrograde perfusion process and alsoproviding means for retaining the RCSP catheter within the coronarysinus during the perfusion process.

In a first aspect, the invention comprises a catheter having aninflatable member, preferably a balloon, mounted to the exterior surfaceof the catheter. The balloon is adapted for expansion or inflationbetween an inflated state and a retracted state. Means are providedbetween at least a portion of the interior surface of the balloon andthe exterior surface of the catheter to prevent inadvertent sticking ofthe balloon body to the catheter as the balloon is inflated. The meansfor preventing the sticking include injecting a liquid lubricant betweenthe balloon and the catheter body, positioning a spring between theballoon and catheter body, and positioning a fluid-permeable sleevebetween the balloon and catheter body. Alternatively, the balloon can bestretched or elongated prior to adhering the balloon to the exteriorsurface of the catheter. Still another means for preventing sticking ofthe balloon to the catheter would be roughening the contact surfaces ofone of the balloon and catheter body to thereby reduce the effectivesurface area of contact between these two elements. The roughening canbe performed by chemical, mechanical, or electrical processes. Thecatheter incorporating means to prevent sticking of the balloon to thecatheter body can be used in any application in which an expandablemember such as a balloon is mounted to the exterior surface of thecatheter body and in which it is desirable to prevent sticking of theballoon body to the catheter body during the inflation of the balloon.The preferred application of the invention is for use in a coronarysurgical application.

In another aspect, the invention comprises a catheter which is ideallysuited for use during the retrograde administration of cardioplegiasolution. The catheter preferably comprises a catheter body and aninflatable member such as a balloon mounted to the exterior of thecatheter body. The balloon is spaced from the proximal and distal endsof the catheter body a sufficient distance so that the balloon can bepositioned immediately adjacent to and intermediate the inferior venacava and the coronary sinus ostia during the retrograde administrationof cardioplegia solution while the proximal and distal ends of thecatheter body are positioned above the heart.

In the preferred embodiment, a stopcock is mounted to the proximal endof the catheter body, and a guide wire is selectively received in boththe stopcock and the catheter body to provide support and rigidity forproper positioning of the catheter.

In still another aspect, the invention comprises a method for theretrograde administration of cardioplegia solution to the heart throughthe coronary sinus. A cardioplegia catheter is inserted into thecoronary sinus through the coronary sinus ostia. A restriction catheterhaving a balloon provided thereon is positioned externally of the heartso that the balloon is immediately adjacent to the coronary sinus and atleast one of the diaphragm and the inferior vena cava. The restrictioncatheter balloon is inflated so that the balloon bears against thecoronary sinus ostia and one of the diaphragm and inferior vena cava.The inflated balloon restricts the coronary sinus ostia and preventsremoval of the cardioplegia catheter during the retrogradeadministration of cardioplegia solution.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described with reference to the drawings inwhich:

FIG. 1 is a plan view of a first embodiment of the improved ballooncatheter according to the invention;

FIG. 2 is a partial, sectional view of the balloon catheter taken alongthe lines 2--2 of FIG. 1 showing the balloon in the retracted state;

FIG. 3 is a partial, sectional view similar to FIG. 2 showing theballoon in the expanded state;

FIG. 4 is a sectional view similar to FIG. 2 showing a second embodimentof the non-sticking catheter according to the invention;

FIG. 5 is a partial, sectional view of the catheter according to theinvention showing the balloon in a partially-inflated state with aportion of the balloon broken away to expose a third embodiment of thenon-sticking means;

FIG. 6 is a partial, sectional view similar to FIG. 5 showing a fourthembodiment of the non-sticking means;

FIG. 7 is a partial, sectional view similar to FIG. 5 showing a fifthembodiment of the non-sticking means;

FIG. 8 is a partial, sectional view similar to FIG. 2 showing a sixthembodiment of the non-sticking means according to the invention;

FIG. 9 is a bottom, perspective view of a heart showing a retentioncatheter according to the invention in position for assisting in theretrograde perfusion process;

FIG. 10 is a plan view of a preferred embodiment of the retentioncatheter assembly according to the invention;

FIG. 11 is a partial, sectional view of a heart showing the retentioncatheter in position with the expandable member in the deflated state;and

FIG. 12 is a sectional view similar to FIG. 11 showing the retentioncatheter in position with the expandable member in the inflated state.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, and to FIGS. 1-3 in particular, a firstembodiment of the catheter 12 according to the invention is shown. Inthis embodiment, the catheter 12 comprises a catheter body 14 having aproximal end 16, a distal end 18, and an expandable member such as aballoon 20 provided on the exterior surface 38 of the catheter body 14.The proximal 22 and distal ends 24 of the balloon are securely fastenedto the exterior surface 38 of the catheter body 14 by suitable means,such as a conventional adhesive. An inflation lumen 26 is provided inthe catheter body 14 so that the distal end of the inflation lumen 26 isfluidly connected to the interior of the balloon 20, and the proximalend of the lumen 26 has a conventional luer connector 28 providedthereon to control the fluid flow to the balloon 20. A main lumen 30extends from the proximal end 16 to the distal end 18 of the catheterbody 14. Preferably, multiple fluid apertures 32 are provided adjacentthe distal end 18 of the catheter body 14, and a conventional luerconnection 34 is provided on the proximal end 16 of the catheter body14.

The catheter 12 according to the invention is an improvement over theknown catheter structures because it includes means to preventinadvertent sticking or adhesion of the expandable portion of theballoon body 20 to the exterior surface 38 of the catheter body 14. Afirst embodiment of the means to prevent sticking or adhesion comprisesa spring 40 which is positioned on the exterior surface 38 of thecatheter body 14 and extends between the proximal 22 and distal ends 24of the balloon 20. The spring 40 is helically wound around the exteriorsurface 38 of the catheter body 14 in such a manner to prevent or atleast restrict the amount of direct contact between the balloon 20 andthe exterior surface 38 of the catheter body 14, intermediate theproximal and distal ends 22, 24 of the balloon 20. The spring ispositioned so that it permits the free flow of the inflation fluidthrough the inflation lumen to the hollow interior of the balloon 20.

In the preferred embodiment of the catheter 12, the catheter body 14 andballoon 20 are both formed from similar, silicon materials.Unfortunately, the use of two, similar, silicon materials can result inthe inadvertent sticking of the interior surface of the balloon 20 tothe exterior surface of the catheter body 14 as the balloon 20 isinflated. The spring 40 according to the invention overcomes theseproblems by preventing or restricting contact between the interiorsurface of the expandable portion of the balloon and the exteriorsurface of the catheter body 14.

FIG. 4 shows a second embodiment of the means for preventing inadvertentsticking of the balloon 20 to the catheter body 14. In this embodiment,a compatible liquid lubricant 50 is injected into the space between theinterior surface 36 of the balloon 20 and the exterior surface 38 of thecatheter body 14. The lubricant prevents inadvertent sticking or contactbetween the balloon 20 and catheter body 14. Preferably, the lubricant50 is selected from materials which will achieve the desired benefit ofpreventing sticking without having an adverse impact on the materialsselected for the balloon 20 and catheter body 14. Examples of suitableliquid lubricants include glycerin and hydrogel coatings such aspolyvinylpyrrolidone, silicone oil, and polydimethyl siloxane.

The inflatable balloons shown in FIGS. 1-4 are manually inflated,whereas the balloons which will be shown in FIGS. 5-8 are auto-inflateballoons. The auto-inflate balloon depicted in FIG. 5 shows a thirdembodiment of the non-sticking means according to the invention. In thisembodiment, a mesh sleeve 52 is provided intermediate the interiorsurface 36 of the balloon 20 and the exterior surface 38 of the catheterbody. The sleeve has a plurality of filaments 54 interwoven to restrictor prevent contact between the interior surface 36 of the balloon 20 andthe exterior surface 38 of the catheter body 14 without restrictingfluid flow from the main lumen 30 through the inflation apertures 56into the balloon 20. Preferably, the sleeve 52 extends between theproximal and distal ends 22, 24 of the balloon 20, and the sleeve 52 issecurely adhered to the exterior surface 38 of the catheter body 14 byconventional adhesives. Multiple inflation apertures 56 are provided inthe catheter body 14 and fluidly connect the main lumen 30 to the hollowinterior of the balloon 20.

FIG. 6 shows a fourth embodiment of the non-sticking means according tothe invention. In this embodiment, a sleeve 60 having a plurality offluid apertures 62 formed therein is adhesively mounted to the exteriorsurface 38 of the catheter body 14 and preferably extends between theproximal and distal ends 22, 24 of the balloon 20. The fluid aperture 62of the sleeve 60 cooperates with apertures formed in the catheter body14 to fluidly interconnect the main lumen 30 of the catheter body to thehollow interior of the balloon 20. This embodiment of the non-stickingmeans is formed by first adhesively mounting a solid sleeve 60 to theexterior surface 38 of the catheter body 14 and then simultaneouslyforming the fluid aperture 62 in the sleeve 60 and the catheter body 14by conventional means. Finally, the balloon 20 is mounted to thecatheter body 14. With this structure, alignment of the sleeve fluidaperture 62 and apertures in the catheter body is ensured.

FIG. 7 shows a fifth embodiment of the non-sticking means according tothe invention. In this embodiment, at least one of the exterior surface38 of the catheter body 14 and the interior surface 36 of the balloon 20are roughened by conventional means. In FIG. 7, the exterior surface 38of the catheter body 14 has been roughened to reduce the area of contactbetween the interior surface 36 of the balloon 20 and the exteriorsurface 38 of catheter body 14. With this reduced area of contactbetween the two elements, the likelihood of sticking of the balloon 20to the catheter body 14 is reduced.

The surfaces of the balloon and catheter body can be roughened by anyone of several, conventional methods. For example, the surfaces can beroughened by a chemical process in which the area to be roughened issprayed, dipped, or wiped with a suitable oxidizing agent which willroughen the surface which is exposed thereto. A plasma oxidizing processis shown in U.S. Pat. No. 5,133,422 which is expressly incorporatedherein by reference.

An alternative to the chemical process would be a mechanical rougheningof the surface. For example, the surface can be rubbed or scraped withan abrasive material. Alternatively, the surface can be roughened by aconventional, electrical, corona treatment. In this process, the toplayer of the surface being treated is ionized through a weak electricaldischarge. The ionization of the surface causes release of certainmolecules, thereby roughening the surface on a microscopic level.

FIG. 8 shows yet another means for avoiding sticking of the balloon 20to the catheter body 14. In conventional catheter structures, theballoon is mounted to the exterior surface of the catheter body in asubstantially relaxed condition. In the embodiment seen in FIG. 8, theballoon 20 is elongated prior to mounting to the exterior surface 38 ofthe catheter body 14. In this embodiment, the pre-tensioned balloon isless likely to inadvertently stick to the exterior surface of thecatheter body because of the stress levels already present in thematerial. Preferably, the balloon 20 is elongated 50% prior to mountingto the exterior surface 38 of the catheter body 14.

Any catheter having an expandable balloon mounted thereto in which thepotential exists for the inadvertent sticking or tacking of the balloonto the catheter body can incorporate one or more of the non-stickingmeans described above. As is apparent to a person skilled in the art,one or more of the non-sticking means can easily be used in a vastnumber of known catheter structures and applications. The preferredembodiment of the catheter easily adapted to incorporate any one of thenon-sticking means is described further below and is particularly suitedfor use during coronary bypass surgery. In this embodiment, a retentioncatheter 112 according to the invention comprises a catheter body 114having a proximal end 116 and a distal end 118. Preferably, aconventional stopcock 120 is provided on the proximal end 116 of thecatheter body 114. The distal end 118 preferably comprises a rounded,closed tip 122. An expandable member such as a selectively inflatedelastomeric balloon 124 is mounted on the exterior surface of thecatheter body 114. A lumen 126 extends through the catheter body 114from the proximal end 116 to the balloon 124, and the interior of theballoon 124 is fluidly connected to the lumen 126 by a plurality offluid apertures 128. Preferably, the catheter body is formed from apliable material such as silicone or polyvinyl chloride, and the balloon124 is formed from a highly elastic material such as silicone whichtightly adheres to the exterior surface of the catheter body 114 in itsunexpanded state. Pressurized fluid, supplied from a suitable source,passes through the stopcock 120, lumen 126, and fluid apertures 128 toinflate the balloon 124 to suitable fluid pressures. It is important tonote that in the preferred embodiment of the retention catheter, thecatheter has only a single lumen and the only outlet of fluid from thelumen 126 is the fluid apertures 128 leading to the closed balloon 124.Therefore, any and all pressurized fluid which is directed into thecatheter 112 is directed solely to the inflation or expansion of theballoon 124.

In the preferred embodiment, a guide wire 130 is received inside thecatheter lumen 126 for ease of positioning the catheter. However, it isto be understood that the guide wire 130 is not a necessary element ofthe invention. The guide wire 130 comprises a handle 132 positioned onthe proximal end 133 of the guide wire 130. Preferably, the length ofthe guide wire is dimensioned so that the distal end 134 of the guidewire 130 is immediately adjacent the rounded distal tip 122 of thecatheter body 114 when the guide wire 130 is fully received inside thecatheter lumen 126. In FIG. 10, the guide wire 130 is shown partiallyremoved from the catheter body 114.

The retention catheter 112 is ideally suited for use during theretrograde administration of cardioplegia solution into the coronarysinus. As seen in FIGS. 9, 11, and 12, the process of retrogradeadministration of cardioplegia solution begins with the step ofintroducing the RCSP catheter 136 via the right atrium into the coronarysinus 138 through the coronary sinus ostia 140. Preferably, the RCSPcatheter 136 is inserted with the balloon 142 in the unexpanded state(not shown). Eventually, the RCSP catheter balloon 142 is inflated, andpressurized cardioplegia solution passes through the catheter 136 intothe coronary sinus 138. A preferred embodiment of the RCSP catheter isseen in U.S. Pat. No. 5,505,698 to Booth et al. which is expresslyincorporated herein by reference.

Prior to the retrograde administration of cardioplegia solution throughthe RCSP catheter 136, the retention catheter 112 is positionedexternally of the heart 144 for enhancing the retrograde administrationof cardioplegia solution. In the preferred method, the distal end 118 ofthe retention catheter 112 and guide wire 130 assembly is slidunderneath the heart 144, preferably inside the percutaneous sack andforced up and around the body of the heart 144 until the balloon 124 ofthe retention catheter 112 is positioned immediately adjacent theinferior vena cava 146, coronary sinus 138, middle cardiac vein 148, andsmall cardiac vein 150. Preferably, the retention catheter 112 is sopositioned with the balloon 124 in the unexpanded state. In thisposition, the proximal 116 and distal 118 ends of the retention catheter112 preferably are both positioned above the heart 144 so that the endscan be secured to the surgical drapes or other suitable structuresufficient to hold the catheter 112 in position with respect to theheart 144. Once the catheter is properly positioned, the guide wire 130is removed therefrom, and then the stopcock 120 is fluidly connected toa suitable source of pressurized fluid for inflation of the balloon.

In most surgical procedures in which the heart is perfused in theretrograde manner, a venous cannula 154 is inserted into the rightatrium and the inferior vena cava 146. The cannula 154 is used to drawvenous blood from the patient during bypass. FIGS. 11 and 12 depict oneexample of a venous cannula 154 positioned in the right atrium andinferior vena cava 146. The retention catheter 112 is preferably usedsimultaneous with a venous cannula 154 positioned in the inferior venacava 146. However, use of the venous cannula 154 in this process is byno means a necessity.

Once the venous cannula 154 and RCSP catheter 136 are properly inposition, the balloon 124 of the retention catheter 112 can be inflated.Pressurized fluid from a suitable source fluidly connected to theproximal end 116 of the catheter body 114 flows through the stopcock120, the lumen 126, and the fluid apertures 128 resulting in inflationof the balloon 124. As the balloon inflates, it bears against thepatient's diaphragm 156, the inferior vena cava 146, and the bottomsurface of the heart 144 including the coronary sinus 138, middlecardiac vein 148, and small cardiac vein 150. The diaphragm 156 andinferior vena cava 146 with the cannula 154 received therein arerelatively immovable compared to the heart tissue and the several veins.Therefore, as the balloon 124 expands, it compresses the coronary sinus138 immediately adjacent the sinus ostia 140, the middle cardiac vein148, and the small cardiac vein 150. With the balloon 124 in theexpanded state as seen in FIG. 12, the coronary ostia 140 is pinchedpartially closed. The partial closure of the ostia prevents theinadvertent removal of the inflated RCSP catheter 136 from the coronarysinus 138. Simultaneous with the pinching of the ostia 140, the middleand small cardiac veins 148, 150 will also be compressed as a result ofthe expansion of the balloon 124. Preferably, the balloon 124 isinflated a sufficient amount to pinch closed the middle and smallcardiac veins 148, 150, thereby preventing cardioplegia solution frompassing through either of these veins, back into the right atrium of theheart 144.

In the preferred embodiment, the catheter body 114 is 43 centimeters intotal length, and the balloon 124, in the expanded state, is eightcentimeters in length. Preferably, the balloon 124 is positionedequidistant along the length of the catheter body 114 so that each endof the balloon 124 is approximately 17.5 centimeters from thecorresponding end of the catheter. With this structure, there issufficient length of the catheter body 114 both proximally and distallyfrom the balloon 124 so that the ends of the catheter body 114 can beeasily secured to the surgical drapes and the like for retaining thecatheter 112 in position once the balloon 124 has been inflated.

Use of the catheter according to the invention is an improvement overthe known balloon catheters because the possibility of the inadvertentsticking of the balloon to the catheter body during inflation isminimized. In addition, use of the retention catheter according to theinvention is an improvement over the known methods for theadministration of cardioplegia solution in the retrograde manner becauseinadvertent removal of the RCSP catheter is minimized, and anyundesirable draining of cardioplegia solution from the middle and smallcardiac veins back into the right atrium is also minimized uponinflation of the properly positioned balloon catheter. These benefitsare achieved without any additional incisions or trauma to the heartthan that which is already encountered in a standard open heart surgicalprocedure.

Reasonable variation and modification are possible within the spirit ofthe foregoing specification and drawings without departing from thescope of the invention.

The embodiments for which an exclusive property or privilege is claimedare defined as follows:
 1. A catheter comprising:a catheter body havingan exterior surface, a proximal end, a distal end, and a first lumenextending through at least a portion of the catheter body; an inflatablemember mounted to the exterior surface of the catheter body adjacent thedistal end, fluidly connected to said first lumen, and adapted forinflation between an expanded state and a retracted state, theinflatable member having a proximal end, a distal end, and an interiorsurface; and a solid sleeve provided on the exterior surface of thecatheter body intermediate the proximal and distal ends of theinflatable member, said sleeve having at least one fluid aperture formedtherein to fluidly connect the interior of the inflatable member withthe first lumen and adapted to prevent inadvertent adhesion of theinterior surface of the inflatable member to the exterior surface of thecatheter body.
 2. A catheter according to claim 1 wherein no fluidapertures are provided on the catheter body, distally from the distalend of the inflatable member.
 3. A catheter according to claim 1 for usein the retrograde administration of cardioplegia solution to a heartwherein said inflatable member is mounted on the exterior surface of thecatheter body substantially equally spaced from the proximal and thedistal ends, the catheter being adapted to be positioned externally ofthe heart, immediately adjacent to and intermediate the inferior venacava and coronary sinus ostia during the retrograde administration ofcardioplegia solution.
 4. A catheter according to claim 3 wherein nofluid apertures are provided on the catheter body, distally from thedistal end of the inflatable member.
 5. A catheter according to claim 1wherein the catheter body and inflatable member are formed from siliconeand the solid sleeve is formed from a material other than silicone.
 6. Acatheter for use in the retrograde administration of cardioplegiasolution, the catheter comprising:a catheter body having an exteriorsurface, a proximal end, a distal end, and a lumen extending through atleast a portion of the catheter body; an inflatable member, having aninterior surface, the inflatable member being mounted on the exteriorsurface of the catheter body substantially equally spaced from theproximal and distal ends and fluidly connected to the lumen, theinflatable member being adapted to be selectively inflated between aretracted state and an expanded state in response to the introduction ofpressurized fluid into the lumen of the catheter body, the catheterbeing adapted to be positioned externally of the heart, immediatelyadjacent to and intermediate the inferior vena cava and coronary sinusostia during the retrograde administration of cardioplegia solution; anda fluid permeable sleeve for preventing inadvertent adhesion of theinterior surface of the inflatable member to the exterior surface of thecatheter body, the sleeve being provided on one of the catheter body andinflatable member intermediate the interior surface of the inflatablemember and the exterior surface of the catheter body, wherein the fluidpermeable sleeve comprises a solid sleeve having at least one fluidaperture formed therein, the fluid aperture adapted to fluidly connectthe first lumen to the inflatable member.
 7. A catheter according toclaim 6 and further comprising a guide wire selectively received insidethe lumen of the catheter body, the guide providing sufficient supportand rigidity for proper positioning of the catheter.
 8. A catheteraccording to claim 7 and further comprising a stopcock provided on theproximal end of the catheter body, the stopcock being fluidly connectedto the lumen and selectively adapted to seal the lumen.
 9. A catheteraccording to claim 6 wherein the sole fluid inlets and outlets of thecatheter body comprise a lumen inlet aperture and at least one inflationaperture.
 10. A catheter according to claim 9 wherein the inflatablemember comprises a proximal end and a distal end, the proximal anddistal ends of the balloon are spaced approximately 17 centimeters fromthe proximal and distal ends of the catheter body.
 11. A catheteraccording to claim 6 wherein the inflatable member comprises proximaland distal ends and the proximal and distal ends of the inflatablemember are spaced intermediate the proximal and distal ends of thecatheter body, the proximal and distal ends of the catheter bodyconfigured to extend far enough so that the proximal and distal ends canbe secured to a suitable support, when the catheter is in use.
 12. Acatheter according to claim 6 wherein the inflatable member has aninterior surface and further comprising a fluid permeable sleeveprovided intermediate the interior surface of the inflatable member andthe exterior surface of the catheter body, wherein the sleeve is adaptedto prevent inadvertent adhesion of the inflatable member to the catheterbody.
 13. A catheter according to claim 6 wherein the inflation memberis formed from an elastic material and the inflation member is mountedto the exterior surface of the catheter body in an elongated state andadapted to prevent inadvertent adhesion of the inflation member to thecatheter body.
 14. A catheter for use in the retrograde administrationof cardioplegia solution, the catheter comprising:a catheter body havingan exterior surface, a proximal end, a distal end, and a lumen extendingthrough at least a portion of the catheter body; an inflatable member,having an interior surface, the inflatable member being mounted on theexterior surface of the catheter body substantially equally spaced fromthe proximal and distal ends and fluidly connected to the lumen, theinflatable member being adapted to be selectively inflated between aretracted state and an expanded state in response to the introduction ofpressurized fluid into the lumen of the catheter body, the catheterbeing adapted to be positioned externally of the heart, immediatelyadjacent to and intermediate the inferior vena cava and coronary sinusostia during the retrograde administration of cardioplegia solution; anda liquid lubricant for preventing inadvertent adhesion of the interiorsurface of the inflatable member to the exterior surface of the catheterbody, said liquid lubricant being provided on one of the catheter bodyand inflatable member.
 15. A catheter according to claim 14 wherein theliquid lubricant is selected from the group comprising silicone oil,glycerin, polyvinylpyrrolidone, and polydimethyl siloxane.
 16. Acatheter according to claim 14 wherein the inflation member is formedfrom an elastic material and the adhesion prevention means comprisesmounting the balloon to the exterior surface of the catheter body in apretensioned elongated state.
 17. A catheter for use in the retrogradeadministration of cardioplegia solution, the catheter comprising:acatheter body having an exterior surface, a proximal end, a distal end,and a lumen extending through at least a portion of the catheter body;an inflatable member, having an interior surface, the inflatable memberbeing mounted on the exterior surface of the catheter body substantiallyequally spaced from the proximal and distal ends and fluidly connectedto the lumen, the inflatable member being adapted to be selectivelyinflated between a retracted state and an expanded state in response tothe introduction of pressurized fluid into the lumen of the catheterbody, the catheter being adapted to be positioned externally of theheart, immediately adjacent to and intermediate the inferior vena cavaand coronary sinus ostia during the retrograde administration ofcardioplegia solution; and wherein at least one of the exterior surfaceof the catheter body and the interior surface of the balloon isroughened to prevent inadvertent adhesion of the interior surface of theinflatable member to the exterior surface of the catheter body.
 18. Acatheter according to claim 12 wherein said at least one of the exteriorsurface of the catheter body and the interior surface of the balloon arechemically roughened.
 19. A catheter according to claim 12 wherein saidat least one of the exterior surface of the catheter body and theinterior surface of the balloon are mechanically roughened.
 20. Acatheter according to claim 17 wherein said at least one of the exteriorsurface of the catheter body and the interior surface of the balloon areelectrically roughened.